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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01645891
Other study ID # TC02-2012-01
Secondary ID
Status Completed
Phase N/A
First received July 18, 2012
Last updated February 8, 2017
Start date April 2012
Est. completion date November 2016

Study information

Verified date February 2017
Source Electrochemical Oxygen Concepts, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of this study is to evaluate the effectiveness of CDO in combination with standard moist wound therapy (MWT) on wound healing as compared to standard MWT alone.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

- Subjects 30-90 years of age at the time of Informed Consent

- Subjects with type 1 or type 2 Diabetes Mellitus with a non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers

- Subjects who have an ulcer with a duration of at least 4 weeks, but not greater than 52 weeks at time of screening

- Subjects with an index ulcer measuring between 1 - 10 cm2 in area after debridement (Area = length x width)

- Subjects with a diabetic foot ulcer(s) at or below the malleoli

- Subjects who demonstrates adequate arterial perfusion defined as either:

- transcutaneous oxygen measurements of the dorsum of the foot > 30 mm Hg with a skin perfusion pressure > 30 mm Hg, or an ankle/brachial index (ABI) above 0.7, with documented confirmation of adequate arterial perfusion, or

- a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening, or

- absolute toe pressure of > 30 mm Hg

- Subject and/or caregiver must be able and willing to learn and perform the duties of dressing changes

- Subjects are able and willing to comply with standardized off-loading regimen (such as a fixed ankle walker)

Exclusion Criteria:

- Subjects < 30 or > 90 years of age at the time of Informed Consent

- Subjects with Target Ulcers with a duration < 4 weeks or > 52 weeks

- Subjects with ulcers measuring less than 1 cm2 or greater than 10 cm2 in area (Area = length x width) after debridement at the time of screening

- Subjects whose ulcer decreased in area by > 30 % during the 1 week screening period

- Subjects with evidence of gangrene on any part of affected limb

- Subjects with active Charcot's foot on the study limb

- Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment

- Subjects with active infection at the time of screening

- Subjects with a target ulcer which has exposed tendons, ligaments, muscle, or bone

- Subjects with active malignancy, excluding non-melanoma skin cancer

- Subjects with a history of malignancy on study limb

- Subjects in whom oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline

- Subjects who are currently receiving or has received radiation or chemotherapy within 3 months of randomization

- Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening

- Subjects who are pregnant at the time of screening

- Subjects who are undergoing active renal dialysis

- Subjects who have a known immune insufficiency, excluding Diabetes Mellitus

- Subjects with a history of peripheral vascular repair within 14 days of screening

- Subjects with a current deep vein thrombosis (DVT)

- Subjects with ulcers due to Raynaud's disease

- Subjects with and ulcer due to acute thrombophlebitis

- Subjects with inadequate perfusion to support healing

- Subjects with necrotic wounds covered with eschar or slough

- Subjects with wounds with fistulae or deep sinus tracts of unknown depth

- Subjects who are receiving palliative care

- Subjects who have a HbA1c > 12% (uncontrolled hyperglycemia)

- Subjects whose target ulcer has a known etiology of: malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum

- Subjects with a documented history of alcohol or substance abuse within 6 months of screening

- Subjects who are currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results

- Subjects with a known allergy to dressing materials, including occlusive dressings and the adhesives on such dressings

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CDO electrochemical tissue oxygenation system
The TransCu O2® device is a non-invasive, electrochemical tissue oxygenation system intended for use with lower-cost wound dressings for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and other skin wounds through the continuous diffusion of oxygen (CDO). The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing
Moist Wound Therapy
Moist Wound Therapy in combination with sham or deactivated device

Locations

Country Name City State
United States Clinical Research Associates of Central PA Altoona Pennsylvania
United States Foot and Ankle Specialists of the Mid-Atlantic Annapolis Maryland
United States Richard C. Galperin, DPM, PA Dallas Texas
United States Sacramento Foot & Ankle Center Fair Oaks California
United States Limb Preservation Platform Fresno California
United States Roy O. Kroeker, DPM , Inc. Fresno California
United States Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc. Glendale Arizona
United States William Blake Partners, LLC Grapevine Texas
United States The Research Center Hialeah Florida
United States Houston Foot & Ankle Houston Texas
United States Foot and Ankle Specialists of the Mid-Atlantic Kensington Maryland
United States Clinical Research Medical Center Las Vegas Nevada
United States Aiyan Diabetes Center Martinez Georgia
United States Complete Family Foot Care McAllen Texas
United States Phoenix Medical Research Miami Florida
United States Foot and Ankle Specialists of the Mid-Atlantic Pasadena Maryland
United States Associated Foot and Ankle Specialists Phoenix Arizona
United States Alamo Clinical Research San Antonio Texas
United States Clinical Trials of Texas San Antonio Texas
United States The University of Texas Health Science Center at San Antonio San Antonio Texas
United States Center for Clinical Research, Inc San Francisco California
United States Doctors Research Network South Miami Florida
United States Southern Arizona VA Health Care System Tucson Arizona
United States Orthopedic Research Institute West Palm Beach Florida
United States PMG Research of Wilmington, LLC Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Electrochemical Oxygen Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete (100%) wound closure defined as complete re-epithelialization without drainage Complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12 12 weeks or wound closure
Secondary Time to 50%, 75% and 100% wound closure Time to 50%, 75% and 100% wound closure by using digital photography & computerized planimetric analysis 12 weeks or wound closure
Secondary Pain Reduction Pain Reduction from day 0 to week 12 or closure using the Wong-Baker Faces™ Pain Rating Scale 12 weeks or closure
Secondary Quality of Life Quality of Life improvement from day 0 to week 12 or closure using the Diabetic Foot Ulcer Scale - Short form week 12 or wound closure
Secondary Epithelial tissue development Epithelial tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score week 12 or wound closure
Secondary Granulation tissue development Granulation tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score week 12 or wound closure
Secondary Total Bates-Jensen Wound Assessment Tool Score Total Bates-Jensen Wound Assessment Tool Score from day 0 to week 12 or closure week 12 or wound closure
See also
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